DEVICE: Burnshield (06007645000215)

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Device Record History
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Device Identifier (DI) Information
Burnshield
550004
In Commercial Distribution
550004
BURNSHIELD (PTY) LTD
06007645000215
GS1

1
635842958 *Terms of Use
BURNSHIELD BURN BLOTTS 3.5ML
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47694 Burn gel
A substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K943728 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 3.5 Milliliter
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Device Record Status
781d39f1-a884-48e8-83f6-3527aa6ce101
April 15, 2024
7
November 01, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
16007645000212 1200 06007645000215 In Commercial Distribution BOX
06007645004534 5 06007645000215 In Commercial Distribution BOX
36007645004535 100 06007645004534 In Commercial Distribution BOX
36007645005747 3 06007645000215 In Commercial Distribution BOX
46007645005744 300 36007645005747 In Commercial Distribution BOX
06007645005746 25 06007645000215 In Commercial Distribution BOX
26007645005740 40 06007645005746 In Commercial Distribution BOX
06007645000017 10 06007645000215 In Commercial Distribution BOX
36007645000018 50 06007645000017 In Commercial Distribution BOX
66007645000217 25 06007645000215 In Commercial Distribution BOX
76007645000214 40 66007645000217 In Commercial Distribution BOX
26007645000219 100 06007645000215 In Commercial Distribution BOX
86007645000211 12 26007645000219 In Commercial Distribution BOX
16007645004531 10 06007645004534 In Commercial Distribution BOX
26007645004538 10 16007645004531 In Commercial Distribution BOX
06007645009683 6 06007645000215 In Commercial Distribution BOX
16007645009680 50 06007645009683 In Commercial Distribution BOX
06007645010429 16 06007645000215 In Commercial Distribution BOX
16007645010426 100 06007645010429 In Commercial Distribution BOX
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+27114405171
sales@burnshield.com
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